Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

Trial Title: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

NCT ID: NCT06274268

Condition: Sarcopenia
Oncology
Physical Inactivity
Toxicity Due to Chemotherapy

Conditions: Official terms:
Sarcopenia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective cohort study

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Sarcopenia diagnostic test
Description: the study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients.
Arm group label: Interventionnal

Summary: The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers. The main question it aims to answer is : Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment? The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.

Detailed description: The present study is single-center within the Centre Hospitalier Metropole Savoie, interventional and prospective, and will be carried out in patients suffering from cancer and having received an indication for systemic oncological treatment, in first line, The inclusion visit (V1) will take place during the first chemotherapy session and will include study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients. The duration of these examinations carried out in addition to clinical practice is estimated at 15 minutes and does not involve any particular risks for patients. Data collection 1 (R1) will be carried out during the second course of chemotherapy, data collection 2 (R2) will be carried out 6 months from the start of treatment, and data collection 3 (R3) at 12 months from the start of treatment. inclusion, based on standardized extraction of the medical file. An exploratory study will be offered to patients treated in the context of adjuvant or neoadjuvant breast cancer and treated by the AC/PACLITAXEL protocol which will involve a second optional visit (optional V1.1) during the first injection of PACLITAXEL . An optional data collection (R1.1) will take place during the first cycle to collect actimetry data. And an optional data collection (R1.2) will take place 2 weeks after the theoretical end of PACLITAXEL in order to collect on file the grades of neuropathies and toxicities over the interval. The visits will be carried out as part of the usual patient care. Apart from the measurement of impedancemetry, grip strength, the chair rise test and actimetry, no other clinical, paraclinical intervention or biological analysis will be induced by the protocol.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients over 18 years old - Patient with a diagnosis of a histologically proven solid malignant tumor with an indication for systemic treatment during initial treatment. - CT/PET performed within 45 days before initiation of systemic treatment. - Patient able to sign informed consent for participation in the study - Patient affiliated to a social security system Exclusion Criteria: - History of cancer in the five years preceding inclusion other than localized skin or cervical cancers. - Patient with cancer not requiring systemic treatment. - Pregnant women. - Patient with a pace maker or defibrillator - Patient deprived of liberty or benefiting from a legal protection measure

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centre Hospitalier Metropole Savoie

Address:
City: Chambéry
Zip: 73000
Country: France

Status: Recruiting

Contact:
Last name: aurelie fillon

Phone: 04.79.96.58.13
Email: aurelie.fillon@ch-metropole-savoie.fr

Contact backup:
Last name: florence jego

Phone: 04.79.96.58.13
Email: florence.jego@ch-metropole-savoie.fr

Investigator:
Last name: aurelie fillon
Email: Principal Investigator

Investigator:
Last name: nathalie marques
Email: Sub-Investigator

Start date: June 24, 2024

Completion date: May 1, 2028

Lead sponsor:
Agency: Centre Hospitalier Metropole Savoie
Agency class: Other

Collaborator:
Agency: Université Savoie Mont Blanc
Agency class: Other

Source: Centre Hospitalier Metropole Savoie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06274268